New Work Will Necessitate New Resources

In the latest draft of 21st Century Cures, FDA is faced with multiple new responsibilities, many of them time and people-consuming. In response to the House Energy and Commerce Committee’s request, FDA is working on quantifying the specific burden. However, even without that analysis, it is already clear that FDA will need additional monies if there are substantial, new statutory requirements. As Cures is currently drafted, there are just such substantial, new mandates.

Further, FDA has been honest that responsibilities specified in law have priority over administrative initiatives and non-statutory programming within the agency. This is the correct interpretation of constitutional law. In the real world, it may also result in important, but lesser statutory mandates robbing resources from substantively higher priorities. What is specified in law will receive the first dollars, regardless of the consequences.

Congress is in the process of making clear that it wants more from FDA (details and specifics are TBD). What isn’t clear: whether there is sufficient political support for funding increases and where the money would come from. As we have reported numerous times these Analysis and Commentary posts, the prospects for appropriations increases for any federal agency are small, regardless of the importance of their mission. In FDA’s case, this is compounded by a critical tension -- the importance of the mission is offset by Congressional concerns about accountability.

On its face, this seems fair -- FDA stewardship of funds is the key to matching accountability, responsibilities, and funding. However, it puts the agency in something of a bind in a time of multiplying responsibilities. As the agency tries to do it all, the odds increase that there will be a let-down somewhere. This, then, erodes confidence in the agency and makes it less likely that additional monies will become available.

This sounds familiar because it is similar to the situation that FDA found itself in a decade ago, in the years just before the Alliance was created. In 2007, the advisors on the agency’s Science Board issued a report that concluded that FDA’s problems were caused, in large part, by inadequate funding. To the extent that FDA runs far more smoothly and with much greater success today, an important reason is that Congress invested additional funding in the agency. Nonetheless, the agency’s responsibilities are not static and continue to grow. As Congress considers adding new work for the agency, it must provide the resources in order for that work to be successful.

Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.